Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

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Beyond "Subpar Service" And "Difficult Sponsors" To The Symmetries Of Success

Subpar customer service at CDMOs is no longer something sponsors tolerate; there’s enough competition where they can move on. The other side of the coin is how difficult sponsors sink to the bottom of CDMO priorities; providers also have options. Here's an analysis less about technical components of outsourcing, and more on mutual satisfactions from working together to fulfill contractual arrangements and missions.

GUEST COLUMNISTS

Your 7 Decisions To Make Before MES Configuration
Don't wait until manufacturing execution system (MES) configuration to answer these 7 questions. Define your manufacturing process before digitizing it.
The Orange Book's Blind Spot: Process Stability And Capability
The current system for assuring therapeutic equivalence contains structural blind spots. Companies must evolve rather than merely adding corrective actions.
Are You Falling Behind On Intelligent Pharmaceutical Manufacturing?
With a focus on small molecule drug product manufacture, let's take a closer look at the efficiencies gained through closed-loop control, PAT, digital twins, and more.
DEA Reveals Hidden Costs Of Analytical Validation Guidelines
By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.
Qualification And Validation Of Depyrogenation Tunnels And Autoclaves
Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization.
FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.
CDMO Selection Beyond Capabilities And Price
Some of the most useful information relevant to CDMO selection is also the hardest to obtain. Here are suggestions for uncovering data that tells the whole capability story.
August 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

PHARMA OUTSOURCING WHITE PAPERS

Overcoming Challenges To High-Concentration Formulation Development
Explore how the S-HiCon™ platform optimizes high-concentration therapeutic antibody formulations, overcoming stability and manufacturability challenges to deliver safe, effective therapies.

Controlling Complexity In ADC Formulation Development
ADC formulation development requires a molecule-specific approach that accounts for the interplay between antibody, linker, and payload, and the stability trade-offs that mAb development experience cannot fully anticipate.
Addressing Plasmid DNA Challenges In Large-Scale AAV And Lentivirus Manufacturing Using dbDNA
Plasmid DNA supply and regulatory concerns constrain large-scale viral vector manufacturing. Here, we examine whether enzymatically generated dbDNA can deliver comparable rAAV and rLV production outcomes.
Tablet Manufacturing Technologies For Solid Drug Formulation
Compressed tablets are common oral solid dosages that contain the API and various excipients. Learn about the critical steps in selecting manufacturing methods and excipients to achieve the desired therapeutic effects and stability.
Annex 1: Sterile Fill/Finish For Early Phase Clinical Supplies
Meeting stringent requirements for sterile fill/finish operations hinges on robust contamination control strategies, advanced isolator technology, and rigorous integrity testing to ensure patient safety.
Transitioning Your Product From Phase 1 To Phase 2 Clinical Studies
Strategic partnerships can streamline your transition from Phase 1 to Phase 2 clinical studies, ensuring optimized dosage forms, seamless scale-up, and alignment with patient and study requirements.